Hysterosalpingography is a well known medical procedure which involves recording images of anatomical structures of the uterus and fallopian uterine tubes. More specifically, during the procedure, an opaque or contrast media fluid is injected into the uterus and the fallopian tubes. Hysterosalpingography is used quite extensively to examine the uterus and fallopian tubes of a female for obstructions or anatomical abnormalities which might impair and prevent insemination or fertilization. It is a frequently performed procedure and to be effective it must, like other medically probative procedures, provide a high degree of accuracy in the resultant diagnosis.
There are, of course, other medical procedures wherein it is necessary to establish access or fluid communication with the uterus or the fallopian tubes. For instance, it is sometimes possible to inject fluid medicaments into the uterus or fallopian tubes for therapeutic purposes. Further, the insertion of instruments into the uterus or fallopian tubes may be indicated for procedures such as a biopsy. In any case, there are numerous procedures wherein it is desirable or necessary to establish access or fluid communication with either the uterus or the fallopian tubes.
Devices and systems which are presently being used to gain access for medical instruments into the uterus and fallopian tubes, or which are being used for the injection of a fluid contrast media into the uterus and fallopian tubes for a hysterosalpingography procedure, must pass through the cervix. Most incorporate a catheter which must somehow be anchored to the uterus to prevent dislodgment of the catheter during the procedure. How this is done, of course, differs from device to device. Several examples can be cited.
U.S. Pat. No. 5,104,377 which issued to Levine for an invention entitled "Uterine Access Device with Automatic Cervical Adjustment" discloses a device for accessing the uterus to either manipulate the uterus or to introduce fluids or other devices into it. To hold the device in place during its use, a distal balloon is inserted into the uterus and inflated while, at the same time, a proximal balloon is partially inserted into the cervical canal. The proximal balloon is then inflated, part of the inflated balloon is in the cervical canal and part is proximal to the exterior os of the cervix to capture the cervix between the inflated balloons, and thereby anchor the catheter. This can, however, be quite uncomfortable for the patient. Fluids can then be injected into the uterus through the catheter.
U.S. Pat. No. 4,089,337 which issued to Kronner for an invention entitled "Uterine Catheter and Manipulator with Inflatable Seal" discloses a flexible catheter which is inserted into the uterus against the resistive force of a spring biased disc. Once the catheter is positioned, a balloon is inflated in the uterus. The catheter is then anchored between opposing forces. One is the spring force of the spring biased disc, which tends to withdraw the catheter from the uterus. The other force is generated by the inflated balloon which resists the withdrawal. However, if the spring force is too weak, the catheter may be able to move back and forth through the cervical canal. This can cause trauma and can cause the distal tip of the catheter to move uncontrollably in the uterus. On the other hand, if the spring force is too strong, the cervix is pinched and there can be unwanted discomfort for the patient.
U.S. Pat. No. 4,430,076 which issued to Harris for an invention entitled "Combined Uterine Injector and Manipulative Device" discloses a multi-lumen catheter having a balloon which is inflatable once it is properly positioned in the uterus. A handle, which firmly engages the catheter, is prepositioned on the catheter to limit its insertion into the uterus. Depending upon the location where the handle is engaged with the catheter, the catheter is somewhat free to move back and forth through the cervical canal.
The examples of uterine catheters and injectors set forth above, all pertain to references which disclose devices that provide direct access only into the uterus. For hysterosalpingography this may be sufficient. On the other hand, it may not be sufficient. For instance, it is known that procedures which rely on the injection of a contrast media directly into the uterus, to obtain information about the condition of the fallopian tubes, result in approximately thirty to fifty (30-50%) false positive diagnoses for tubal obstruction. The unfortunate consequence of using systems and devices which provide direct access into only the uterus is; if it is ever determined that direct access into the fallopian tube is necessary, the system or device must be changed. Most often, this means there is a need for a second operation.
It can also happen that an incomplete or ineffective diagnosis may lead to unnecessary surgery. For example, the inability to determine the proper condition of the fallopian tubes may require an exploratory laparoscopy. Other examples can be given. Suffice it to say, any effective and efficacious intrauterine procedure is preferable.
In light of the above, it is an object of the present invention to provide a method and apparatus for establishing access or fluid communication with the uterus and the fallopian tubes of a female for diagnostic or therapeutic purposes which includes a cervical access catheter that can be adjusted according to the particular patient's anatomy to firmly, but gently, anchor the catheter across the cervical canal. It is another object of the present invention to provide a method and apparatus for establishing access or fluid communication with the uterus and the fallopian tubes which provides direct access into the fallopian tube. Still another object of the present invention is to provide a method and apparatus for establishing access or fluid communication with the uterus and the fallopian tubes which allows the flexibility of establishing direct access into the fallopian tube whenever it has been determined that access into only the uterus is ineffective for the particular diagnostic or therapeutic procedure. Another object of the present invention is to provide a method and apparatus for establishing access or fluid communication with the uterus and the fallopian tubes which is efficacious and, thereby, avoids unnecessary surgery. Yet another object of the present invention is to provide an apparatus for establishing access or fluid communication with the uterus and the fallopian tubes which is manufacturable, relatively easy to use, and comparatively cost effective.